FDA’s Post-Market Surveillance and Reporting for Medical Devices
25 Jul 2024
Medical device manufacturing is a lucrative sector. However, it requires strict vigilance and must be controlled by regulations. These regulations are not meant to control the manufacturing process of these medical devices only. Instead, it sticks up with them even after devices have reached the market, something known as post-market surveillance.
Post-market surveillance can comprise various forms and programs. In this blog, we will cover those programs under the pretext of FDA.
What Exactly is Post-Market Surveillance?
Post-market surveillance is an active systematic collection and analysis of data about marketed medical devices. Manufacturers use post-market surveillance to monitor their products while in the market. It’s the systematic generation and collecting of data on the device and its practical applications, which makers can subsequently make use of, such as.
- Knowing exactly how the product is used after it is released into the market
- finding problems with the device’s usage or design that can compromise safety
- collecting information to create new or improved models of a device
FDA and Post-Market Surveillance
Under FDA, a system known as MedWatch is used for post-market surveillance. Using this system, public and doctors can report any adverse reactions associated with a marketed drug or a medical device.
FDA also has the FDA Adverse Event Reporting System (FAERS). FARES supports post-market safety surveillance for all the therapeutic biologic products and approved drugs by monitoring their safety.
Evaluation of Drugs and Medical Devices Before Marketing
Drugs and medical devices are thoroughly evaluated before they are approved for marketing (by the FDA). This pre-market evaluation is done by CDER (Center for Drug Evaluation and Research). During its evaluation, the CDER examines all the clinical data, efficacy, and safety profiles of the drug/product. All of this is done to ensure that the benefits of these products are greater than their risks.
Now, although CDER plays an important role in evaluating medical devices and products before their marketing, it is still essential to perform post-market surveillance on them.
Importance of Post-Market Surveillance
The most obvious reason for performing post-market surveillance on a medical device/drug is determining and reporting any side effects that were not expected during pre-market studies. Moreover, the FDA also has a system of risk management programs and post-marketing surveillance that can identify adverse events (such as poisonings) which did not appear during the approval process. This information is used to update drug labeling and sometimes to re-evaluate the marketing decision.
Understanding FAERS and MedWatch
FDA Adverse Event Reporting System (FAERS)
The FAERS is a computerized database that supports FDA’s post-market surveillance for the approved therapeutic biological and drug products. The aim of FAERS is improving public health by providing the tools that can store and analyze safety reports in the best way.
Reports gathered in FAERS are evaluated by multidisciplinary staff safety evaluators (including epidemiologists) from CDER’s Office of Surveillance and Epidemiology. Acting upon these reports, FDA can decide to take regulatory actions for improving public safety and protecting the public health. Examples of these actions can include:
- Re-evaluation of previous approval
- Updating a product’s labeling information, or
- Sending out a “Dear Health Care Professional” letter
The MedWatch Program
The MedWatch program allows the public and healthcare professionals to voluntarily report adverse reactions and problems they may encounter with medical products. The program also ensures that any new safety information gets quickly communicated to the medical community. The data stored in MedWatch form gets fed into the AERS (Adverse Event Reporting System) database.
MedWatch for Prescription Medical Products Manufacturers
FDA requires manufacturers of prescription products to submit adverse event reports. MedWatch website contains necessary information which manufacturers can use to report the adverse events. Device manufacturers are also required to submit if they deviate from CGMP (Current Good Manufacturing Practices) regulations.
- Error and accident reports or
- Drug quality report
FDA’s Unannounced Inspections
After FDA approves a medical device/drug for marketing, it places different mechanisms in place to ensure that
- The firms comply with terms and conditions of approval mentioned in the application, and
- The firms manufacture their products in a controlled and consistent fashion.
For this purpose, FDA also makes unplanned and unannounced visits of the production facilities time to time.
Medication Error Reports
According to the National Coordinating Council for Medication Error Reporting and Prevention, a medication error is defined as:
“any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, procedures, and systems, including prescribing; order communication; product labeling, packaging, and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.”
FDA gets its medication error reports on the marketed drugs, generic drugs, over-the-counter drugs, prescription drugs, non-vaccine biological products and devices. Also, the staff from CDER medication errors program
- Reviews the medication error reports sent to the USP-ISMP Medication Errors Reporting Program and MedWatch,
- Analyzes the data to provide feedback to staff at FDA, and
- Evaluates any reported casualties from medication error.
Drug Shortages
As per FDA’s policy, shortage of medically necessary products must be prevented at all costs. However, it is important to remember that these shortages can still occur due to several reasons, e.g.
- Marketing decisions and conditions,
- Enforcement issues,
- Unavailability of raw products and packaging components, etc.
Thus, ensuring that drugs are present in market according to the demand is also an important component of FDA’s post-market surveillance activities.
Therapeutic Inequivalence Reporting
Switching brands of drugs can lead to many problems. Either they can become completely ineffective or can pose harmful effects on the human body. To counter such problems, FDA created the Therapeutic Inequivalence Action Coordinating Committee (TIACC) in CDER on 14th September 1988. This Committee works to identify and evaluate reports of therapeutic toxicities and failures that are indicative of one product being inequivalent to a similar product.
Taking care of Post-Market Surveillance Requirements
As a medical device manufacturer, the FDA requires you to comply with its post-market regulations. Since post-market surveillance comprises multiple activities, it can become difficult for you to complete all of them alone. Plus, there is always a risk of being non-conformative to one (or more) of these requirements. With our expertise in post-market surveillance activities, you can be rest assured that about your compliance with these requirements.
To learn more about our post market surveillance services, contact us today at tsquality.ch
